APPLICATION
ANDA077533
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-02
LATEST ACTION
2025-09-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TERBINAFINE HYDROCHLORIDEDiscontinued
TERBINAFINE HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL
Approval history
2025-09-11Labeling · Supplement 14 · standardAP
2025-09-11Labeling · Supplement 17 · standardAP
2016-01-10Labeling · Supplement 12 · standardAP
2016-01-10Labeling · Supplement 10 · standardAP
2012-07-12Labeling · Supplement 5 · standardAP
2011-09-20Labeling · Supplement 3AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.